UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024207 |
|---|---|
| Receipt number | R000027866 |
| Scientific Title | Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2022/10/17 11:01:56 |
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Basic information
Public title
Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Acronym
Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title
Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title:Acronym
Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
improvement of the physical activity and abilities and the trunk imbalance, the activities of dairy living
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the activities of daily living
Key secondary outcomes
standing and sitting postures and trunk balance, mortality, the physical activity, acute myocardial infarction, PTCA and PTA, CHF require hospital care, cerebrovascular event require hospital care, pneumonia, malignancy, bone fracture and event of fall
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitation for 15 minutes using digital mirror device
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients receiving hemodialysis or peritoneal dialysis
Key exclusion criteria
1.patients who has difficulty in going to hospital
2.patients who judged that a doctor was inappropriate
3.patients who receives exercise function rehabilitation now
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Hamada |
Organization
Juntendo University Hospital
Division name
Nephrology
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5802-1065
chieko@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Nohara |
Organization
Juntendo University Hospital
Division name
Nephrology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-3111
Homepage URL
nozaki-n@juntendo.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
Tel
0338309609
nozaki-n@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027866
